Drug Certification

Amgen Inc. said Friday that it won't receive government approval of its second-generation anemia treatment by the end of this month, as it had expected. The Thousand Oaks-based biotechnology company had forecast Food and Drug Administration clearance for Aranesp during the first half of 2001. Amgen, the world's largest biotechnology company, said discussions about what to put on the label are continuing with the FDA and are encouraging.

Schering-Plough Corp. said the Food and Drug Administration agreed to allow it to sell its already marketed hepatitis C drug, Rebetol, as an individual treatment--a decision long-awaited by patients seeking a more effective way to use the medicine. The ruling allows Schering-Plough to market separate packages of Costa Mesa-based ICN Pharmaceuticals Inc.'s Rebetol capsules, which are available only in a combination package with an injectable interferon drug called Intron-A.

A booster shot against whooping cough that works for adults won approval from the Food and Drug Administration. Sanofi-Aventis' Adacel is for people ages 11 to 64. A month ago, the FDA OKd the first-ever whooping cough booster, GlaxoSmithKline's Boostrix, which is for 10- to 18-year-olds. The cough, so strong it can result in broken ribs, was once thought to be history thanks to effective vaccination of babies and toddlers.

Chiron Corp. and Gen-Probe Inc. have won the first U.S. approval of a test to screen donated blood for the deadly West Nile virus typically transmitted to humans by mosquito bites. Blood banks in the United States have been using experimental tests, including Chiron and Gen-Probe's Procleix, to screen for the virus, the Food and Drug Administration said Thursday in a statement. The tests have identified the virus in about 1,600 donations, which were then destroyed, the FDA said.

Pfizer Inc. said the Food and Drug Administration had approved its medication for pain caused by nerve damage from diabetes or shingles, but it is still under review for treating partial seizures in adults. Pfizer said that Lyrica was the first FDA-approved treatment for this pain, often described as burning, tingling, sharp or stabbing or as pins and needles in the feet, legs, hands or arms.

A new vaccine that combines four childhood immunizations has won approval from the U.S. Food and Drug Administration, Merck & Co. said Tuesday. The vaccine, called Proquad, is approved to protect children 12 months to 12 years of age against measles, mumps, rubella and chickenpox.

The supply outlook for flu vaccine this year improved Wednesday as two manufacturers cleared crucial regulatory hurdles. Chiron Corp.'s troubled factory in England passed a key Food and Drug Administration inspection, putting the company on track to return to the U.S. market. British pharmaceutical giant GlaxoSmithKline, meanwhile, received FDA approval to sell its flu shots in the U.S. for the first time. Taken together, the developments eased worries about a severe vaccine shortage.

Abbott Laboratories said it won U.S. approval of a carotid-artery stent for preventing strokes, beating Johnson & Johnson, the world's biggest device maker, in the race to compete with a device sold by Guidant Corp. Abbott will comply with the Food and Drug Administration's request for continued research on the device after approval, a company spokesman said.

Amgen Inc., the world's largest biotechnology company, said Monday that U.S. regulators approved its Aranesp drug to treat anemia in cancer patients undergoing chemotherapy, creating competition for Johnson & Johnson's top-selling product Procrit. Thousand Oaks-based Amgen said the Food and Drug Administration would allow the sale of Aranesp, a longer-lasting form of the company's older anemia drug Epogen, as well as Procrit. "Obviously, there is a benefit in terms of lower frequency of dosing.